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Sponsors and Collaborators: |
Rikshospitalet HF University of Oslo School of Pharmacy |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00199745 |
The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
Condition | Intervention | Phase |
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Muscular Diseases |
Drug: atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity |
Estimated Enrollment: | 53 |
Study Start Date: | October 2005 |
The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Norway | |
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF | Recruiting |
Oslo, Norway, 0027 | |
Contact: Martin P Bogsrud, medical student +4795948194 m.p.bogsrud@studmed.uio.no | |
Contact: Kjetil Retterstøl, MD +4723075603 kjetil.retterstol@rikshospitalet.no | |
Principal Investigator: Kjetil Retterstøl, MD | |
Sub-Investigator: Martin P Bogsrud, medical student | |
Sub-Investigator: Gisle Langslet, MD | |
Sub-Investigator: Leiv Ose, MD | |
Sub-Investigator: Kjell E Berge, MD |
Principal Investigator: | Kjetil Retterstøl, MD | Lipidklinikken, Rikshospitalet-Radiumhospitalet HF |
Principal Investigator: | Anders Åsberg, Associate Professor | Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo |
Study ID Numbers: | Muskelbiopsistudie Lipid05-06, S-05229 (REK - Sør), 13041 (NSD) |
Study First Received: | September 12, 2005 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00199745 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
statin statins statin therapy adverse events side effect |
Myotoxicity atorvastatin Statin Therapy Atorvastatin Therapy |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Nervous System Diseases |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |